BackgroundThe enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that would severely restrict medical data research have been raised.ObjectiveOur objective is to explain the changes in data protection laws that apply to medical research and to discuss their potential impact.MethodsAnalysis of ethicolegal requirements imposed by the GDPR.ResultsThe GDPR makes the classification of pseudonymised data as personal data clearer, although it has not been entirely resolved. Biomedical research on personal data where consent has not been obtained must be of substantial public interest.ConclusionsThe GDPR introduces protections for data subjects that aim for consistency across the EU. The proposed changes will make little impact on biomedical data research.

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The definition of data might at first glance seem prosaic, but formulating a definitive and useful definition is surprisingly difficult. This question is important because of the protection given to data in law and ethics. Healthcare data are universally considered sensitive (and confidential), so it might seem that the categorisation of less sensitive data is relatively unimportant for medical data research. This paper will explore the arguments that this is not necessarily the case and the relevance of recognizing this. The categorization of data and information requires re-evaluation in the age of Big Data in order to ensure that the appropriate protections are given to different types of data. The aggregation of large amounts of data requires an assessment of the harms and benefits that pertain to large datasets linked together, rather than simply assessing each datum or dataset in isolation. Big Data produce new data via inferences, and this must be recognized in ethical assessments. We propose a schema for a granular assessment of data categories. The use of schemata such as this will assist decision-making by providing research ethics committees and information governance bodies with guidance about the relative sensitivities of data. This will ensure that appropriate and proportionate safeguards are provided for data research subjects and reduce inconsistency in decision making.

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.

We review current applications of Big Data in diabetes care and consider the future potential by carrying out a scoping study of the academic literature on Big Data and diabetes care. Healthcare data are being produced at ever-increasing rates, and this information has the potential to transform the provision of diabetes care. Big Data is beginning to have an impact on diabetes care through data research. The use of Big Data for routine clinical care is still a future application. Vast amounts of healthcare data are already being produced, and the key is harnessing these to produce actionable insights. Considerable development work is required to achieve these goals.